Not yet recruitingNAINTERVENTIONAL

Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.

This study, called 'Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia', aims to see if a gentle light treatment can help people living with ataxia. Ataxia affects balance, walking, and thinking skills, making daily life harder. This new treatment, called photobiomodulation, uses red and near-infrared light on the head. Scientists believe this light could boost energy in brain cells, reduce stress, and improve blood flow. Previous small studies suggest it might help with balance and brain function. This pilot study is a first step to find out if it's safe and effective for people with ataxia to potentially improve their balance and thinking.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Central Lancashire

Enrolment target

Start

01 Jun 2026

Estimated completion

10 Dec 2027

Ataxia

What is this study about?

Ataxia is a condition that makes it hard to coordinate movements, leading to problems with balance, walking, and even thinking clearly. These issues can make everyday tasks challenging and reduce someone's independence and quality of life. Currently, there aren't many treatments that can significantly help with these symptoms, so researchers are always looking for new and gentle ways to support people with ataxia.

This study is investigating a treatment called photobiomodulation (tPBM). This involves using a special light, similar to red and infrared light that can't be seen, on your head. The idea is that this light can give a boost to the tiny energy factories inside your brain cells, help reduce harmful stress, and improve blood flow to the brain. Think of it like giving your brain cells a gentle wake-up call to help them work better.

Previous research has shown that this type of light therapy might help healthy people and those with certain conditions to think more clearly and move better. Because ataxia affects both movement coordination and the ability to focus, scientists are hopeful that this light therapy could be a promising non-drug treatment. This study is designed as a small, early trial to see if tPBM is safe and has any positive effects on balance and thinking skills for people with ataxia. It’s an exciting step towards potentially finding new ways to help manage ataxia symptoms.

Key takeaways

This study explores a potential new light therapy for ataxia.
It aims to improve balance and thinking skills in people with ataxia.
It's a pilot study to check safety and if the treatment shows promise.
Participation involves short light therapy sessions and assessments.
You may receive active light therapy or a 'sham' (inactive) version.
The risks are generally expected to be low.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old and have been diagnosed with ataxia. You should be able to walk by yourself for at least five minutes, even if you use a walking aid. You also need to be able to stand safely for balance tests, again, with or without help.

It's important that your general health is stable, including your blood pressure and heart rate. If you take medication, you should have been on the same stable dose for at least four weeks before starting the study. Your eyesight and hearing should be good enough to complete tests, even if you wear glasses or hearing aids. You must also be able to understand and agree to take part.

However, you can't join if you've had a head injury in the past or currently, if you're taking medications that affect your brain, or if you have skin problems on your forehead or scalp. If you have another major nerve condition affecting your balance or thinking, or if you're already having brain stimulation therapy, or have a history of migraines or sensitive skin/allergies, you won't be able to participate. This helps ensure the study is safe and that the results clearly show the effects of the light therapy.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have a diagnosis of ataxia?
Can you walk independently for at least 5 minutes (with aids if needed)?
Can you stand safely for balance tests (with aids if needed)?
Are your medications stable for at least 4 weeks?
Do you NOT have a history of head injury, migraines, or sensitive skin/allergies?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the active light treatment called photobiomodulation or a sham (inactive) version, which looks and feels the same but doesn't have the light. This is to help researchers compare the effects accurately. You would have several visits to the study centre where assessments of your balance and thinking skills will be carried out. These assessments might involve standing tests, walking tasks, and computer-based puzzles. The light treatment itself would involve a device placed on your head for a short period. The researchers will explain exactly what each visit involves and how long it will take. You will not be given any new medication as part of this study, and there will be no long-term follow-up after your final assessment. The total time you would be involved in the study is relatively short, focusing on acute (immediate) effects.

Potential risks and benefits

Potential benefits of taking part might include an improvement in your balance or thinking skills, especially if the light therapy proves effective. Even if you receive the sham treatment, you would be helping advance medical understanding of ataxia. The potential risks are expected to be low, as the light therapy is generally considered safe and doesn't involve drugs. However, some people might experience mild, temporary skin irritation or discomfort from the device, or rarely, headaches. You will be closely monitored during the study, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Central Lancashire
Verified postcode
Preston, United Kingdom

Common questions

What is photobiomodulation?

It's a gentle light therapy that uses red and near-infrared light on your head to potentially improve brain cell function and blood flow.

Will I know if I'm getting the real treatment or the 'sham' treatment?

No, you won't know because it helps us get accurate results. Neither will the researchers, until after the study is complete. This is called a 'blinded' study.

How long does each treatment session take?

The information suggests a session might be around 24 minutes, but the study team will provide exact details.

What kind of tests will I have?

You'll have tests to check your balance, walking, and thinking abilities, likely involving standing, moving, and computer tasks.

Do I need to stop my current medications for this study?

No, you don't need to stop. However, you should have been on a stable dose of your medications for at least four weeks before starting the study.

How to find out more

Jonathan J Sinclair, DSc

jksinclair@lancashire.ac.uk +44787565153 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.